Online Program

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Thursday, September 13
Thu, Sep 13, 11:45 AM - 1:00 PM
Various Rooms
Roundtable Discussions

TL06: Benefit-Risk Assessment for Medical Products (300606)

*Chul Ahn, FDA/CDRH 

Keywords: benefit and risk, regulatory decision making, Bayesian

Characterizing uncertainty in the assessment of benefits and risks of medical products is a major challenge for regulatory decision makers. This roundtable will discuss approaches to assess benefit and risk and their implications for regulatory decision making. Especially, we will discuss procedures (frequentist and Bayesian) for simultaneously evaluating benefits and risks that have been recently considered by many researchers.